CannabisPhase 1NCT03546790
Laboratory Smoking of Marijuana "Blunts"
A Phase 1 study testing Marijuana in people with Cannabis, run by Battelle Memorial Institute at 1 site in United States.
Trial summary
This is a double-blind within-subjects clinical laboratory study comparing the product appeal and abuse liability-related subjective effects of different flavored cigar wrappers for marijuana blunts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- Marijuana
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 30 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently living in Baltimore City or Baltimore County, MD;
- Able to read, understand, and sign informed consent;
- 18-55 years old;
- Currently smokes marijuana blunts;
- Designation of Medically Healthy for Research by the Study Physician; and
- Willing to abstain from illicit drug use other than marijuana for the duration of the study.
Who cannot join
- BAC > 0.020% as measured by alcohol breathalyzer;
- Meets DSM-5 criteria for severe current or lifetime Cannabis Use Disorder;
- Meets DSM-5 criteria for any current Axis I disorder, other than current mild or moderate Cannabis Use Disorder;
- Self-reported current desire to stop marijuana use;
- Self-reported current asthma, chronic obstructive pulmonary disease, hypertension, cardiovascular disease or any other medical illness that precludes participation;
- Has difficulties with blood draws or poor venous access;
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- History of blood donation in the past 30 days or receiving blood products within the past 2 months prior to any experimental visit;
- Among females, current pregnancy or lactation or attempting to get pregnant, or at risk of becoming pregnant;
- Acute illness which will require participant to be rescheduled
Trial locations and contacts
1 site in 1 country.
United States1 site
Battelle Memorial Institute
Baltimore, Maryland, 21209
About this study
This is a double-blind within-subjects clinical laboratory study comparing the product appeal and abuse liability-related subjective effects of different flavored cigar wrappers for marijuana blunts.
- Conditions
- Cannabis
- Being tested
- Marijuana
- Keywords
- Cannabis
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarijuanaDrug
Marijuana smoked via blunts with different cigar wrappers
| Study group | Role | What they receive |
|---|---|---|
| Flavor 1 | Experimental | Grape flavored tobacco cigar wrapper Receives: Drug: Marijuana |
| Flavor 2 | Experimental | Chocolate flavored tobacco cigar wrapper Receives: Drug: Marijuana |
| Flavor 3 | Experimental | Tobacco flavored tobacco cigar wrapper Receives: Drug: Marijuana |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puff topography
Total inhalation volume
Measured: During marijuana blunt smoking
Secondary outcomes (3)
Carbon monoxide
Exhaled breath carbon monoxide (ppm)
Measured: Immediately after marijuana blunt smoking
Subjective drug effects
Ratings of "good" and "high"
Measured: Immediately after marijuana blunt smoking
Measures of demand
Number of units an individual would purchase at varying price points
Measured: Immediately after marijuana blunt smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start10 Apr 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Battelle Memorial Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wallace B Pickworth, PhD, Principal investigator, Battelle Memorial Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546790
- Sponsor's protocol ID
- BMI-104112
- Status last verified
- Sep 2019
- First submitted
- 23 May 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory Smoking of Marijuana "Blunts"
- ClinicalTrials.gov ID
- NCT03546790
- Acronym / sponsor ID
- BMI-104112
- Conditions
- Cannabis
- Keywords
- Cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Battelle Memorial InstituteUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind within-subjects clinical laboratory study comparing the product appeal and abuse liability-related subjective effects of different flavored cigar wrappers for marijuana blunts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flavor 1 | Experimental | Drug: MarijuanaGrape flavored tobacco cigar wrapper |
| Flavor 2 | Experimental | Drug: MarijuanaChocolate flavored tobacco cigar wrapper |
| Flavor 3 | Experimental | Drug: MarijuanaTobacco flavored tobacco cigar wrapper |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Currently living in Baltimore City or Baltimore County, MD;
- Able to read, understand, and sign informed consent;
- 18-55 years old;
- Currently smokes marijuana blunts;
- Designation of Medically Healthy for Research by the Study Physician; and
Key exclusion criteria (9 listed)
- BAC > 0.020% as measured by alcohol breathalyzer;
- Meets DSM-5 criteria for severe current or lifetime Cannabis Use Disorder;
- Meets DSM-5 criteria for any current Axis I disorder, other than current mild or moderate Cannabis Use Disorder;
- Self-reported current desire to stop marijuana use;
- Self-reported current asthma, chronic obstructive pulmonary disease, hypertension, cardiovascular disease or any other medical illness that precludes participation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MarijuanaMarijuana smoked via blunts with different cigar wrappers | Drug | Flavor 1, Flavor 2, Flavor 3 |
Primary outcome
Puff topography
Time frame: During marijuana blunt smoking
Total inhalation volume
3 secondary outcomes
Carbon monoxide
Time frame: Immediately after marijuana blunt smoking
Subjective drug effects
Time frame: Immediately after marijuana blunt smoking
Measures of demand
Time frame: Immediately after marijuana blunt smoking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wallace B Pickworth, PhD principal investigator
Battelle Memorial Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Marijuana in people with Cannabis, run by Battelle Memorial Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Puff topography (time frame: During marijuana blunt smoking). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.